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Covid-19: Pfizer-BioNTech vaccine is rolled out in US

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4836 (Published 14 December 2020) Cite this as: BMJ 2020;371:m4836

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  1. Janice Hopkins Tanne
  1. New York

Stephen Hahn, director of the US Food and Drug Administration, issued an emergency use authorization on 11 December approving the Pfizer-BioNTech vaccine against the coronavirus. Distribution throughout the US began on Sunday 13 December.1

On Thursday the FDA’s independent advisory panel had voted in favor of an emergency use authorization.2 The panel will this week consider a second vaccine, made by Moderna, whose approval also seems likely.

Nearly three million doses of the Pfizer vaccine are being sent from manufacturing facilities to the delivery services UPS and FedEx, which will distribute them to 636 locations around the US. Gustave Perna, an army general and chief operating officer of the US government’s Operation Warp Speed, told a press conference that he expected 145 sites nationwide to receive the vaccine on 14 December. Another 425 sites will receive it the next day. and the remaining 66 sites will get it on 16 December.3 The vaccine must be kept extremely cold and is packed in special containers with dry ice.

Perna said he expected that by the end of the year there would be enough vaccine to immunize 20 million people. Distribution of the Pfizer-BioNTech vaccine—and of Moderna’s, if approved—will continue well into next year. Moncef Slaoui, chief adviser to Operation Warp Speed, said that he expected 100 million of the US’s 330 million population to be immunized by the first quarter of 2021.4

Two doses

Americans are advised to continue wearing masks, practicing social distancing, avoiding indoor crowds, and frequently washing their hands. Cases continue to increase rapidly in the US, with 207 444 new cases recorded on 12 December and a total of 16.3 million cases.5

The vaccine is about 95% effective, clinical trials have found. It must be administered in two doses, 21 days apart, and is approved for people ages 16 and older. Because of severe allergic reactions in two health workers who received the vaccine in the UK, the FDA has advised against giving it to people with a history of severe allergic reactions.

First to receive the vaccine will be about 21 million frontline healthcare workers, including staff of care homes, and about three million care home residents. Some may receive the vaccine early this week, but its administration to care home residents will be delayed until about 21 December because of the need to obtain consent.

Persuading Americans to take the vaccine may be the next hurdle. There is hesitancy, particularly among minority groups. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and the FDA’s Hahn are among those volunteering to take the vaccine,6 but the record keeping associated with vaccine administration may increase hesitancy among people who don’t trust the government.

When people receive the first dose of a vaccine they will get a vaccination card indicating which vaccine they had. They must provide their first and last name, their date of birth, the date they received the first and second vaccinations, and where they received them.7

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References

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